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. Author manuscript; available in PMC: 2021 May 28.
Published in final edited form as: Cancer Chemother Pharmacol. 2021 Jan 25;87(5):599–611. doi: 10.1007/s00280-020-04229-3

Table 2.

Dose levels with number of patients, dose delays, dose reductions and dose limiting toxicities (DLTs)

Dose level AR-42 dose (mg) No. of patients enrolled (N=17) No. of dose delays No. of dose reductions No. of patients with a DLT Description of DLT
1A 30 3 0 0 0 ---
2A 60 2a 0 0 0 ---
1B 60 7b 4 2 1 Thrombocytopenia (grade 3)
2B 80 2c 0 0 1 Thrombocytopenia (grade 3)d
Psychiatric disorder (grade 4)d
Expansion cohort 60 3 0 0 ---
a

Grade 2 thrombocytopenia experienced by second patient, so advanced to stage B.

b

Includes 2 cohorts of 3 patients, plus one patient to replace a patient who was non-compliant and not evaluable.

c

First patient withdrew after 2 doses due to progression and was replaced. Second patient experienced a DLT.

d

Grade 3 thrombocytopenia and grade 4 psychiatric disorder at dose level 2B occurred in the same patient, counting as one DLT.